Company and Technology
With offices in Madrid (Spain) and Boston (Massachusetts/USA), PlenOptika is an award winning and fast-growing company that brings cutting-edge optical technology to front-line vision care professionals worldwide. Our core platform technology, the patented QuickSee Wavefront Autorefractor, offers eyecare professionals and healthcare providers an unprecedented combination of clinical power and usability suited equally for the modern clinic, optical retail store, home visit, and global health mission. Through vision driven innovation, PlenOptika is working towards improving the lives of over 1 billion people who lack access to the vision correction they need. Our technology and work have been reported in peer-review journals and recognized with numerous international awards. The company sells products in more than 45 countries.
We are recruiting a Regulatory Affairs Specialist who will be a key member of our regulatory team. The role will involve managing PlenOptika’s Quality Management System, creating and maintaining technical documentation for the new products of the company, and interfacing with regulatory authorities and notified bodies. The position is based at PlenOptika’s Madrid, Spain office, but the scope of work will include supporting our headquarters in Boston, United States.
Principal Duties and Responsibilities
- Create and maintain the Technical Files and Design History Files of the company products
- Ensure the processes described in the company’s Quality Management System are executed and updated as appropriate
- Stay up-to-date with relevant regulations and keep company regulatory affairs in compliance
- Provide the team with technical advice and support in regulatory affairs
- Manage communications with the competent authorities and notified bodies
- Prepare for and lead regulatory audits; resolve any resulting non-conformities
- Support commercial team for registration in new markets (e.g., work with distributors/consultants to prepare documents for registration, legalize/apostille documents)
We are seeking a highly motivated, efficient, and detail-oriented team member capable of taking on key regulatory affairs responsibilities. Our ideal candidate is a self-starter with a strong sense of ownership, eager to work in a startup environment on a variety of challenging projects.
- At least one year of experience in a regulatory affairs or equivalent role
- Bachelor or Master of Science degree in engineering (e.g., Biomedical Engineering), biotechnology, or science field
- Training or experience in quality management systems. Ideally, this would be in the medical device space, i.e., ISO 13485, 21 CFR part 820
- High proficiency in English, both written and verbal
- Understanding of technical documentation and regulatory documents
- Knowledge of medical device regulations (MDR, MDD, FDA, MDR2002)
- Knowledge of the standards related to medical devices (ISO14791; IEC60601; IEC62304; ISO14155)
- Experience in audits with Notified Bodies
- Passion for building cool stuff!
On site in Madrid office
Compensation (base salary)
To be determined according to professional qualifications and experience.
Email firstname.lastname@example.org with your resume and any other relevant information.